Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

The purpose of this research is to develop from enhanced multimodal anesthesia care to verify and optimize ERAS strategies for orthognathic surgery. If the elements of anesthesia care can be accurately controlled, the harmful pressure factors caused by surgery can be minimized and the patients undergoing facial surgery can be improved.

Study Overview

• Status: Enrolling by invitation
• Conditions: Orthognathic Surgery

Detailed Description

Orthognathic surgery (Orthognathic surgery) is currently one of the most commonly performed surgical items in oral and maxillofacial surgery because it corrects facial deformities, improves teeth chewing and face glowing. In general, the kind of operations are performed under nasotracheal intubating general anesthesia.

Due to the patients were required for motionless, low pressure, controlled ventilation, and adequate analgesia during anesthesia undergoing orthognathic surgery, advanced multimodal anesthesia care developing to the Enhanced Recovery After surgery (ERAS) should be conducted under patient safety. The ERAS concept emphasizes the importance of clinical multidisciplinary teamwork cooperation including of oro-surgeon, anesthesiologist, operating and post-anesthesia care nurses. The core elements of ERAS lies in the management of the entire peri-operative period of anesthesia. In clinical practice, focus on entire anesthesia care during the operation includes of precise anesthesia depth, adequate muscle relaxation, multiple modes of pain controlled and adequate analgesia, stable body temperature maintenance, use of goal-oriented infusion therapy, early extubation, and prevention of postoperative nausea and vomiting.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Taiwan
  • Sanmin Dist
    • Kaohsiung, Sanmin Dist, Taiwan, 80756
      • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.

Description

Inclusion Criteria:

• America society anesthesiologist classification class I to III patients undergoing oro-maxillo-facial surgery
• unlimited mouth opening
• nasotracheal intubation general anesthesia for at least 120 minutes.

Exclusion criteria:

• patients with arthritis with limited mouth opening
• diabetes with insulin treatment
• essential hypertension without controlled
• past history of malignant hyperthermia or personal or family history
• persistent liver dysfunction
• chronic renal insufficiency
• body mass index ≧35 kg/m2.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
permitted hypotension during surgery with adequate depth of anesthesia and cardiac output	to decrease intra-operative bleeding as patient undergoing oromaxillofacial surgery, intentional hypotension is allowed. however, adequate depth of anesthesia, proper cardiac output, respiratory parameters, temperatures should be monitored	intraoperative 2-6 hours
consumption of inhaled and intravenous anesthetics	to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated	intraoperative 2-6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to successfully extubate the nasotracheal tube after anesthesia	early extubation allowable	from the end of surgery to the post-anesthesia care, assessed up to one hour
safely discharged from post-anesthesia care unit (postoperative recovery room)	as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.	2 hours
side effects and adverse events	records any abnormal surgical or anesthesia related findings during this admission	intraoperative and postoperative stages, assessed up to 48 hours

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Kuang-I Cheng, Phd, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: anesthesia; orthognathic surgery; prospective analysis
• Other Study ID Numbers: KMUHIRB-F(I)-20210211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No